Computer System Validation Associate

Job Description

Overview: Computer Systems Validation Associate:

Work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. The CSV Associate will respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based system will produce information or data that meet predefined requirements. This position requires the ability to resolve end user problems quickly. You must have excellent communication skills (both verbal and written), must manage time effectively and have strong organizational skills. You must also possess the ability and judgment to escalate support requests if necessary.

Key Duties & Responsibilities: Computer Systems Validation Associate:

Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix

Develop procedures specific to GxP Application SOP’s and provide SOP review for new systems.

Perform Part 11 Assessments for new and existing computer systems

Perform periodic reviews of validated GxP Systems

Maintain GxP System log and update as necessary

Participate in cross-functional project team meetings

Execute the validation protocols, test scripts per Regulatory and GAMP guidance

Perform Risk assessments for GxP systems

Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance’s and regulatory updates

Identify, communicate and escalate project and compliance related issues associated with their projects to project Manager/Management

Conduct training to individuals performing various roles within validation projects

Review and assess the impact of new Patches to validated GxP systems and validation of new patches

Initiate and resolving any non-conformance observes during periodic reviews through change and incident management

Participate and coordinate with CFT for new projects

Other duties as assigned

Education & Experience: Computer Systems Validation Associate:

Associates degree in related field from an accredited college or university preferred

One-year pharmaceutical industry experience preferred

Technical competencies/ Certifications/ Licenses: Computer Systems Validation Associate:

Applicable knowledge of DEA regulations

Must have sound understanding of Drug Regulations, Pharmacopeia, Regulatory Requirement, Laboratory compliance and adherence to cGMP requirements

Knowledge of pharmaceutical principles, practices and applications

Demonstrates ability to perform detail-oriented work with a high degree of accuracy

Effective time management and interpersonal skills

Strong organizational skills, planning skills and must work effectively within teams

Experience in project Management practices and assessing GxP risk, functional and usage risk for any given GxP Application techniques

Familiarity with software development life cycle, GAMP5 approach to software implementation

Maintains a safe working environment.

Organized

Demonstrates a high level of confidence, integrity and motivation

Handles confidential and non-routine information with poise, tact, and diplomacy

Benefits Include: Computer Systems Validation Associate:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.

Full-time